drugset / Trial / NCT07428538

Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)

NCT07428538 ↗

Phase 3 Recruiting 350 enrolled Bausch Health Americas, Inc. Durect · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.

Timeline

Start
2026-01-29
Primary completion
2027-11
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Larsucosterol Small molecule 30 mg Intravenous

Indications